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Edwards School of Medicine","Huntington","West Virginia","25701",{"type":49,"coordinates":1283},[1284,1285],-82.44515,38.41925,{"lat":1285,"lon":1284},[1288,1292],{"name":1289,"role":35,"phone":1290,"phoneExt":37,"email":1291},"Dakota May, MD","304-691-1500","May110@marshall.edu",{"name":1289,"role":31,"phone":37,"phoneExt":37,"email":37},{"facility":1294,"status":90,"city":1295,"state":1280,"zip":1296,"country":46,"countryCode":47,"cosmosGeoPoint":1297,"geoPoint":1301,"contacts":37},"West Virginia Clinical and Translational Science Institute","Morgantown","26506",{"type":49,"coordinates":1298},[1299,1300],-79.9559,39.62953,{"lat":1300,"lon":1299},{"facility":1303,"status":42,"city":1304,"state":1305,"zip":1306,"country":46,"countryCode":47,"cosmosGeoPoint":1307,"geoPoint":1311,"contacts":1312},"University of Wisconsin","Madison","Wisconsin","53719",{"type":49,"coordinates":1308},[1309,1310],-89.40123,43.07305,{"lat":1310,"lon":1309},[1313,1317],{"name":1314,"role":35,"phone":1315,"phoneExt":37,"email":1316},"Rick Stauffacher","608-262-7722","rstauffach@clinicaltrials.wisc.edu",{"name":1318,"role":31,"phone":37,"phoneExt":37,"email":37},"Steven Garlow",{"type":1320,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100353886","a-prospective-multi-center-randomized-controlled-blinded-trial-demonstrating-the-safety-and-effectiveness-of-vns-therapy-system-as-adjunctive-therapy-versus-a-no-stimulation-control-in-subjects-with-treatment-resistant-depression-100353886",false,"NCT03887715","A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression","RECOVER","Inclusion Criteria:\n\nThe patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode.\n\nThe patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.\n\nThe patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.\n\nPatients must maintain a stable medication regimen for at least four weeks before device implantation.\n\nExclusion Criteria:\n\nCurrent or lifetime history of psychotic features in any MDE;\n\nCurrent or lifetime history of schizophrenia or schizoaffective disorder;\n\nCurrent or lifetime history of any other psychotic disorder;\n\nCurrent or lifetime history of rapid cycling bipolar disorder;\n\nCurrent secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;\n\nCurrent suicidal intent; or\n\nTreatment with another investigational device or investigational drugs.","ALL","18 Years",{"count":1331,"type":1332},6800,"ESTIMATED","INTERVENTIONAL",[1335],"NA","Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.",[1338],"Treatment Resistant Depression",[26,1340,1341],"Depression","TRD","2026-06-11",{"date":1344,"type":1345},"2026-06-15","ACTUAL",{"date":1347,"type":1345},"2019-09-26",{"date":1349,"type":1332},"2030-12-31",{"name":5,"class":6},101]